Veteran-Centered Care for Advanced Liver Disease
Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)
This study is testing a new way to care for Veterans with advanced liver disease by using telemedicine to help them talk about their health and treatment options to see if it leads to more discussions about liver transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 8 sites (Little Rock, Arkansas and 7 other locations) |
| Trial ID | NCT06068491 on ClinicalTrials.gov |
What this trial studies
This project aims to improve care for Veterans with advanced liver disease by implementing a whole person, Veteran-centered approach. It utilizes a telemedicine-based nurse care counselor to facilitate discussions about illness severity, patient priorities, and care preferences. The study will evaluate the effectiveness of this approach through a randomized controlled trial at four VA centers, focusing on increasing rates of liver transplantation consideration and serious illness discussions. The findings will help refine the intervention and inform its broader implementation.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 18 to 80 with advanced liver disease who have been in care at a recruiting site for at least one year.
Not a fit: Patients who are non-Veterans, have limited life expectancy, or have already progressed significantly towards liver transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of care and outcomes for Veterans suffering from advanced liver disease.
How similar studies have performed: Previous studies have indicated that patient-centered approaches can effectively address unmet care needs in advanced liver disease, suggesting potential success for this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients will be between 18 and 80 years of age * Patients must be Veterans * Patients must have been in care at one of the recruiting sites with 1 or more encounters in primary care or GI/Hepatology in the last 24 months * Patients must have advanced liver disease, defined by ICD-10 codes for cirrhosis complications (ever) or MELD 3.0 \>12 or MELD-Na \>12 or Fibroscan LSM \>20kpa Exclusion Criteria: * Non-Veteran patients * Patients who do not speak English, do not have access to a telephone or computers, or who are unable to complete a valid informed consent form after three attempts * Patients who have already made significant progress toward our endpoints: a) with prior history of liver transplantation, or b) on the liver transplant waiting list, or c) had formal evaluation for liver transplantation in the past 3 years * Patients with very limited life expectancy (advanced cancer, acute-on-chronic liver failure, and hospice patients) * Patients hospitalized, or in long term facilities or nursing homes at the time they meet inclusion criteria * Patients with chart diagnosis of uncontrolled mental health or schizophrenia
Where this trial is running
Little Rock, Arkansas and 7 other locations
- Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock, Arkansas, United States (Recruiting)
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (Not_yet_recruiting)
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (Recruiting)
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (Recruiting)
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (Not_yet_recruiting)
- Miami VA Healthcare System, Miami, FL — Miami, Florida, United States (Not_yet_recruiting)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (Not_yet_recruiting)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Fasiha Kanwal, MD MSHS — Michael E. DeBakey VA Medical Center, Houston, TX
- Study coordinator: Juana Campos, MA
- Email: juana.campos@va.gov
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.